Friday, December 16, 2011

Study of Children with Hepatitis B Virus Infection

The Hepatitis B Research Network (HBRN)
Observational Study of Children with Hepatitis B Virus Infection in North America
What is the purpose of this study?
This is a multicenter Hepatitis B virus (HBV) study seeking to enroll approximately 500 children with chronic HBV in order to better evaluate the natural history of this infection in children. We hope to better understand the effects HBV and develop effective treatment strategies with currently available therapies. Study visits will be conducted for 5 years at the time of routine clinical visits. One of the principal aims of the study is to try to understand factors associated with conversion of E antigen to E antibody (which is thought to give the child with HBV a more favorable outlook.) Johns Hopkins represents the only pediatric site in the mid-Atlantic and plans to enroll 80-100 participants. Children who are eligible for future treatment trials will first need to be enrolled in the observational natural history study.

Who can enroll?
Participants are chronically infected with HBV and must be 6 months old to 18 years old.

Who is conducting the research study?
The study is being conducted by researchers at 7 locations in the United States and Canada. It is funded by the National Institutes of Health (NIH). Johns Hopkins University is one of the sites. The research team at this site is:
• Dr. Kathleen Schwarz, MD, Gastroenterologist, Hepatologist, Director, Liver Center, Principal Investigator
• Ying Yuan, MHA, Research coordinator
• Douglas Mogul, M.D., M.P.H. Fellow, Pediatric GI

What will be collected in the study?
The research visits will take place at the same time as the clinical visits. These visits will include a physical exam, medical or interval history, laboratory tests and questionnaires. Blood drawn as part of the study will take place at the same time as routine laboratory tests. The clinical visits and clinical lab tests will be billed to third party payors as is usually done for clinical visits. The research part of the visit will be questionnaires and research blood tests to be done on the same blood draw as the clinical tests.

How long does the study last?
This study lasts for up to 5 years.

What if I don’t want to be in the study or if I want to drop out of the study?
Your participation is voluntary. Your child will receive the same level of care whether you decide to participate or not. You are free to leave the study at any time.

Who can I contact if I have questions?
Please call Ying Yuan at 410-955-9161 or email her at

Please click this link to download a flyer.

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